Overview

Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Status:
Withdrawn
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Treatments:
Pantoprazole
Criteria
Inclusion Criteria:

1. Only patients older than 18 years. Range 18 to 80 years

2. Only cooperative patients

3. Only patients with a need for a coronary angiography, independently from our study

4. Only patients with a left ventricular ejection fraction as demanded in the study
protocol

5. Only patients with clinical symptoms of congestive heart failure, corresponding to New
York Heart Association stage NYHA II or III

6. Only patients without oral or i.v. application of a proton pump inhibitor up to 48
hours prior to the study catheterization

Exclusion Criteria:

1. Manifest or severe accompanying diseases, despite of diabetes mellitus

2. Intravascular or oral application of proton pump inhibitors within the last 48 hours

3. Intake of Metformin within the last 24 hours

4. Status post heart transplant

5. Pregnancy

6. Known intolerance of pantoprazole

7. severe side effects of the tested substance pantoprazole, as well as pharmacokinetic
interactions through CYP isoenzymes

8. Existance of side effects as given in the pantoprazole drug information, among others
disturbances of blood- and lymphatic system, leukopenia, thrombopenia, affections of
gastrointestinal tract, nerve system affections, psychiatric affections, renal or
bladder affections

9. Participation in a other clinical trial